Drugs / RAG-01
Trials 1
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT06351904 | Apr 2024 → Aug 2028 expected | non-invasive bladder urothelial carcinoma | Ractigen Therapeutics. | Recruiting | No outcome recorded |
News releases announcing trial results or a regulatory action · 6
| Date | Issuer | Release |
|---|---|---|
| 2026-03-19 | Ractigen Therapeutics. | Regulatory Ractigen Therapeutics Announces China NMPA IND Approval for Phase II Clinical Trial of saRNA Therapy RAG-01 in Non-Muscle Invasive Bladder Cancer ractigen.com ↗
Ractigen Therapeutics, a pioneering clinical-stage biotechnology company developing innovative small activating RNA (saRNA) therapeutics, today announced that China’s National Medical Products Administration (NMPA) Center for Drug Evaluation (CDE) has approved its Investigational New Drug (IND) application to initiate a Phase II clinical trial of RAG-01 for the treatment of Non-Muscle Invasive Bladder Cancer (NMIBC). |
| 2025-03-24 | Ractigen Therapeutics. | Results Ractigen’s RAG-01 Shows Promising Early Complete Responses in Phase I NMIBC Trial, Data Presented at EAU 2025 ractigen.com ↗
The results demonstrate a remarkable 66.7% complete response (CR) rate in carcinoma in situ (CIS) patients within the two lowest dose cohorts, along with a favorable safety profile, in patients who have failed Bacillus Calmette-Guérin (BCG) therapy. |
| 2025-03-24 | Ractigen Therapeutics. | Results First-in-human study of RAG-01, a novel small activating RNA therapeutic in BCG failure Non-Muscle Invasive Bladder Cancer (NMIBC) patients(Abstract) ractigen.com ↗
Ractigen’s RAG-01 Shows Promising Early Complete Responses in Phase I NMIBC Trial, Data Presented at EAU 2025 |
| 2024-05-21 | Ractigen Therapeutics. | Regulatory Ractigen Therapeutics Secures FDA Fast Track Designation for RAG-01, a First-in-Class saRNA Therapy ractigen.com ↗
Ractigen Therapeutics, a pioneering developer of small activating RNA (saRNA) therapeutics, proudly announces that its flagship program, RAG-01, has been granted Fast Track Designation (FTD) by the U.S. Food and Drug Administration (FDA). |
| 2024-04-26 | Ractigen Therapeutics. | Regulatory Ractigen Therapeutics Announces FDA Approval for RAG-01, a First-in-Class saRNA Therapy for BCG-Unresponsive NMIBC ractigen.com ↗
Ractigen Therapeutics, a leader in the development of small activating RNA (saRNA) therapeutics, announced today that the U.S. Food and Drug Administration (FDA) has approved the company’s Investigational New Drug (IND) application for RAG-01, a groundbreaking saRNA therapy targeting non-muscle invasive bladder cancer (NMIBC). |
| 2023-12-06 | Ractigen Therapeutics. | Regulatory Ractigen Therapeutics Advances into Clinical Stage with Groundbreaking saRNA Drug, RAG-01 ractigen.com ↗
Ractigen Therapeutics, a leader in the field of small activating RNA (saRNA) therapeutics, is excited to announce the submission of a clinical trial application in Australia. |
All press releases naming this drug 8 releases
Evidence & citations 1 cited value
Every value below carries the sentence it was read from. 1 source stands behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | RAG-01 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT06351904 ↗ |